Product code PKS

Device name
Exerciser, Non-Measuring For Stroke Rehabilitation
Medical specialty
Physical Medicine
Device class
1
Regulation number
890.5370
Review panel
PM
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion.
Source
FDA openFDA device classification dataset